傅行弟.熔融法制备非诺贝特缓释胶囊的处方工艺研究[J].安徽医药,2016,20(5):852-855. |
熔融法制备非诺贝特缓释胶囊的处方工艺研究 |
Formulation and preparation process investigation on fenofibrate sustain-released capsule prepared by melting methodFU Xing-di (Anhui Xianqiu Pharmaceutical Co.Ltd,Langxi,Anhui 242131,China) Abstract:Objective |
投稿时间:2016-02-12 |
DOI: |
中文关键词: 非诺贝特 迟效制剂 工艺学,制药 固体分散体技术 |
英文关键词: Fenofibrate Delayed-Action Preparations Technology,Pharmaceutical Solid dispersion technique |
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中文摘要: |
目的 采用熔融法固体分散体技术代替微丸技术制备非诺贝特缓释胶囊。 方法 将主药与辅料熔融制备缓释颗粒,装入胶囊,以进口品为对照,按国家颁布的质量标准中释放度检查条件考查其释放。 结果 两者体外释放基本一致。 结论 熔融法固体分散体技术制备非诺贝特缓释胶囊较微丸技术简单方便,适合工业生产。 |
英文摘要: |
Objective Adopt solid dispersion technique with melting method to replace micropellets-capsule method in preparation of fenofibrate sustain-released capsule. Methods Prepare sustain-released granules with active pharmaceutical ingredient(API) and excipients by melting method,and seal above granules in capsules.Using imported drugs as reference,conduct study vitro-release of self-made sustain-released capsule under the drug-release test conditions in quality standards enacted by SFDA. Results The dissolution rate of self-made fenofibrate sustain-released capsule is basically the same as that of imported one. Conclusion The preparation of fenofibrate sustain-released capsule by solid dispersion techniques with melting method is technologically accessible,and could be widely adopted in industrial manufacture. |
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